A population-based matched cohort study of major congenital anomalies following COVID-19 vaccination and SARS-CoV-2 infection
Year: 2023
Type: article
Study design: Observational Study
Abstract: Evidence on associations between COVID-19 vaccination or SARS-CoV-2 infection and the risk of congenital anomalies is limited. Here we report a national, population-based, matched cohort study using linked electronic health records from Scotland (May 2020-April 2022) to estimate the association between COVID-19 vaccination and, separately, SARS-CoV-2 infection between six weeks pre-conception and 19 weeks and six days gestation and the risk of [1] any major congenital anomaly and [2] any non-genetic major congenital anomaly. Mothers vaccinated in this pregnancy exposure period mostly received an mRNA vaccine (73.7% Pfizer-BioNTech BNT162b2 and 7.9% Moderna mRNA-1273). Of the 6731 babies whose mothers were vaccinated in the pregnancy exposure period, 153 had any anomaly and 120 had a non-genetic anomaly. Primary analyses find no association between any vaccination and any anomaly (adjusted Odds Ratio [aOR] = 1.01, 95% Confidence Interval [CI] = 0.83-1.24) or non-genetic anomalies (aOR = 1.00, 95% CI = 0.81-1.22). Primary analyses also find no association between SARS-CoV-2 infection and any anomaly (aOR = 1.02, 95% CI = 0.66-1.60) or non-genetic anomalies (aOR = 0.94, 95% CI = 0.57-1.54). Findings are robust to sensitivity analyses. These data provide reassurance on the safety of vaccination, in particular mRNA vaccines, just before or in early pregnancy.
Source: Nature Communications
Authors: Clara Calvert, Jade Carruthers, Cheryl Denny, Jack Donaghy, Lisa E. M. Hopcroft, Leanne Hopkins, Anna Goulding, Laura Lindsay, Terry McLaughlin, Emily Moore, Bob Taylor, Maria Loane, Helen Dolk, Joan Morris, Bonnie Auyeung, Krishnan Bhaskaran, Cheryl L. Gibbons, Srinivasa Vittal Katikireddi, Maureen O’Leary, David McAllister, Ting Shi, Colin R. Simpson, Chris Robertson, Aziz Sheikh, Sarah J. Stock, Rachael Wood
Institutions: University of Edinburgh, Public Health Scotland, University of Oxford, Gloucestershire Hospitals NHS Foundation Trust, University of Ulster, University of London, St George's, University of London, London School of Hygiene & Tropical Medicine, University of Glasgow, Victoria University of Wellington, University of Strathclyde
Language: English
Subfield: Obstetrics and Gynecology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $6,290
Awards: G162713286, G2494212245, Non-adherence to treatment: a methodological approach to compensating for its impact in chronic infections, using tuberculosis as a model disease., G2720107755, G3353681036, G339059223, G3526239564, G5231239147, G5274634927, G5519160068, Inequalities in health, G5731206275, G6755285657, G7225038946, G793199012, Long-term vascular health effects of cancer and its treatment, Medicines in pregnancy: predicting harms and benefits of antenatal corticosteroids, G81788182, G8989501819, G9000116783
OpenAlex ID: W4313650271